RemoteNCT07272408
Remote Ischemic Conditioning in Patients Undergoing Primary Percutaneous Coronary Intervention
A study testing Remote ischemic conditioning and Normal primary percutaneous coronary intervention in people with Remote and Ischemic Conditioning, run by Helwan University at 1 site in Egypt.
Trial summary
This study aimed to detect the effects of remote ischemic conditioning on infarct size, global contractility, morbidity, mortality, and renal function in patients undergoing primary percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Remote, Ischemic Conditioning, Primary Percutaneous Coronary Intervention
- What is being tested?
- Remote ischemic conditioning and Normal primary percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 Dec 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 and less than 75 years old.
- Both sexes.
- Patients with new ST-segment elevation at the J-point in V1:V6 leads with the cut-point: ≥ 1mm other than leads V2-V3 where the following cut-points apply: ≥ 2mm in men ≥ 40 years; ≥ 2.5mm in men < 40 years, or ≥ 1.5mm in women regardless of age.
- Patients with new left bundle branch block (LBBB).
Who cannot join
- ST-segment elevation myocardial infarction (STEMI) with cardiogenic shock.
- Severe comorbidities (uncontrolled hypertension, morbid obesity, recent cerebrovascular stroke, respiratory failure, sepsis, and stage 4 \& 5 malignancy).
- End-stage renal disease on hemodialysis.
- Previous coronary artery bypass graft surgery (CABG).
- Myocardial infarct within the previous 30 days.
- Multi-vessel coronary artery disease.
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- Failure of culprit vessel recanalization.
- Conditions precluding use of remote conditioning ie: paresis of upper limb.
- Life expectancy of less than 1 year due to a non-cardiac pathology.
- Patients who receive nephrotoxic drugs such as non-steroidal anti-inflammatory drugs and aminoglycosides.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Remote Ischemic Conditioning in Patients Undergoing Primary Percutaneous Coronary Intervention
This study aimed to detect the effects of remote ischemic conditioning on infarct size, global contractility, morbidity, mortality, and renal function in patients undergoing primary percutaneous coronary intervention.
Read the detailed description
Myocardial infarction (MI) generally refers to segmental (regional) myocardial necrosis, typically endocardial in location, secondary to occlusion of an epicardial artery.
Primary percutaneous coronary intervention (PPCI) is a reperfusion therapy that is carried out in patients who usually have ST-segment elevation MI (STEMI) within a specific time window.
During ischemia, metabolic acidosis occurs due to anaerobic metabolism, and ischemic injury ensues. After restoration of blood supply, reactive oxygen species (ROS) production and local inflammation increase secondary injury.
- Being tested
- Remote ischemic conditioning, Normal primary percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
Remote ischemic conditioning (RIC) was applied to those patients.
Normal primary percutaneous coronary interventionProcedure or surgery
Patients followed the standard primary percutaneous coronary intervention pathway.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Experimental | Remote ischemic conditioning (RIC) was applied to those patients. Receives: Procedure: Remote ischemic conditioning |
| Normal primary percutaneous coronary intervention | Active comparator | Patients followed the standard primary percutaneous coronary intervention pathway. Receives: Procedure: Normal primary percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death
Incidence of cardiac death was recorded.
Measured: 1 month post-procedure
Secondary outcomes (4)
Hospitalization for heart failure
Hospitalization for heart failure post-randomization in the intention-to-treat population was assessed.
Measured: 1 month post-procedure
Contrast induced nephropathy
Contrast induced nephropathy was assessed.
Measured: 1 month post-procedure
Incidence of adverse events
Incidence of adverse events was recorded.
Measured: 1 month post-procedure
Renal impairment
Renal impairment was recorded.
Measured: 1 month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Sep 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemoteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Yousry Mousa, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272408
- Sponsor's protocol ID
- 40-2022
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.